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GENR Genaera Corporation Presents New Preclinical Data for Obesity Compound Trodusquemine (MSI-1436) at CBI Conference
7/27/2007
MSI-1436 is an Allosteric, Noncompetitive Inhibitor of PTP-1B

PLYMOUTH MEETING, Pa., July 27, 2007 /PRNewswire-FirstCall via COMTEX News Network/ --

Genaera Corporation (Nasdaq: GENR) today announced new data from preclinical studies of trodusquemine (MSI-1436) for the treatment of obesity. Michael McLane, Ph.D., Vice President, Nonclinical Development, presented "Trodusquemine: A Novel Small Molecule for the Treatment of Obesity and Related Metabolic Disorders," during the CBI 3rd Annual Obesity Drug Development Summit, July 26-27 in Arlington, Va.

The presentation summarized results from preclinical studies demonstrating that MSI-1436 is a potent, highly-selective and reversible inhibitor of PTP-1B, an enzyme central to the function of both the leptin and insulin pathways. The mechanism of this inhibition, as indicated by in vitro kinetics, is through binding to a site different from the catalytic site of PTP-1B. The in vitro kinetics demonstrates that MSI-1436 is an allosteric, noncompetitive inhibitor of PTP-1B. Data presented also indicates that MSI-1436 crosses the blood brain barrier and is both centrally and peripherally active. These dual locations of MSI-1436 action make the drug a promising therapeutic candidate for both obesity and type 2 diabetes.

"This new preclinical data continues to support our conclusion that inhibition of PTP-1B is the predominant mechanism of action of MSI-1436 and differentiates it from other drugs currently in development," commented Jack Armstrong, President and Chief Executive Officer of Genaera. "By demonstrating MSI-1436 is an allosteric, noncompetitive inhibitor of PTP-1B, we believe the drug is well-positioned to change the treatment paradigm for obese type 2 diabetics, something we have set out to verify in our ongoing clinical development program."

As previously disclosed, preclinical studies also demonstrate that MSI- 1436 suppresses appetite and causes differential weight loss in a mouse model of diet induced obesity (DIO). In addition, MSI-1436 was shown to reduce the size of adipocytes, reduce body fat with no reduction of lean mass, and improve glucose tolerance via inhibition of a unique combination of signaling pathways in the DIO mouse model. MSI-1436 is currently being evaluated in humans in a Phase 1 study for safety and pharmacokinetics in healthy obese volunteers.

About Trodusquemine (MSI-1436)

Trodusquemine (MSI-1436) is the first drug candidate that acts both centrally and peripherally to selectively inhibit the established, validated enzyme target, protein tyrosine phosphatase 1B (PTP-1B), that is central to both insulin and leptin pathways. By inhibiting PTP-1B, MSI-1436 is expected to decrease appetite and normalize blood sugar. Trodusquemine has overcome selectivity concerns that other compounds that target PTP-1B have failed to overcome. Based on this unique mechanism of action, trodusquemine has the potential to bridge the treatment of two of the most serious metabolic diseases, obesity and type 2 diabetes. Trodusquemine has produced consistent, sustainable weight loss in a variety of animal models and appears to overcome metabolic readjustment, which often limits sustained weight loss during caloric restriction. In addition, trodusquemine has shown the ability to address co-morbidities associated with obesity such as abnormal glucose metabolism and cholesterol elevation.

About Genaera

Genaera Corporation is focused on advancing the science and treatment of metabolic diseases. The Company has significant market opportunities with a first-in-class molecule, trodusquemine (MSI-1436), that has the potential to redefine the treatment paradigm for obesity and type 2 diabetes and is presently in a Phase 1 trial in obesity. In addition, Genaera has a value- driven, fully out-licensed partnership with MedImmune, Inc. for a second core program that is presently undergoing Phase 2 clinical testing in asthma. Genaera is committed to directing resources to its core program and the aggressive clinical development of its key assets to build stockholder value. http://www.genaera.com.

This announcement contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties, known and unknown. Forward-looking statements reflect management's current views and are based on certain expectations and assumptions. Such statements include, among others, statements regarding these preliminary results, clinical development plans and prospects for Genaera's programs including trodusquemine (MSI-1436), the IL-9 antibody program, LOMUCIN(TM), or squalamine. You may identify some of these forward-looking statements by the use of words in the statements such as "anticipate," "believe," "continue," "develop," "expect," "plan" and "potential" or other words of similar meaning. Genaera's actual results and performance could differ materially from those currently anticipated and expressed in these and other forward-looking statements as a result of a number of risk factors, including, but not limited to: Genaera's history of operating losses since inception and its need for additional funds to operate its business; the costs, delays and uncertainties inherent in scientific research, drug development, clinical trials and the regulatory approval process; the risk that clinical trials for Genaera's product candidates, including trodusquemine (MSI-1436), the IL-9 antibody program, LOMUCIN(TM), or squalamine may be delayed or may not be successful; the risk that Genaera may not obtain regulatory approval for its products, whether due to adequacy of the development program, the conduct of the clinical trials, changing regulatory requirements, different methods of evaluating and interpreting data, regulatory interpretations of clinical risk and benefit, or otherwise; Genaera's reliance on its collaborators, in connection with the development and commercialization of Genaera's product candidates; market acceptance of Genaera's products, if regulatory approval is achieved; competition; general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industry; and the other risks and uncertainties discussed in this announcement and in Genaera's filings with the U.S. Securities and Exchange Commission, all of which are available from the Commission in its EDGAR database at http://www.sec.gov as well as other sources. You are encouraged to read these reports. Given the uncertainties affecting development stage pharmaceutical companies, you are cautioned not to place undue reliance on any such forward-looking statements, any of which may turn out to be wrong due to inaccurate assumptions, unknown risks, uncertainties or other factors. Genaera does not intend (and it is not obligated) to publicly update, revise or correct these forward-looking statements or the risk factors that may relate thereto.

SOURCE Genaera Corporation

Investor Relations of Genaera Corporation, [phone]; or Media, Susan Neath of Porter Novelli Life Sciences, [phone], [e-mail], for Genaera Corporation http://www.genaera.com/
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